Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma

NCT07547007 | Recruiting

• 2 other identifiers: CHMS250062025-A01123-46
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate the effect of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients with multiple myeloma. The main question it aims to answer are : Does this logn term, individualized and hybrid adapted physical activity program improve quality of life in multiple myeloma patient ? What are the effects of this program on effort tolerance, pain, muscular mass, osteolytic lesions, tolerance to treatment, response to treatment? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will be randomised in 2 groups.

• control group: patients will receive only advices about physical activities benefit
• interventional group: This group will be offered a program of adapted physical activities mixing sessions at home (remote) and sessions at the hospital (in person).

Conditions

Multiple Myeloma (MM)

Keywords

physical activity; multiple myeloma; control group

Outcome Measures

Primary Outcomes (1)

• compare EORTC-QLQ-C30 summary score at 6 months between both groups

  EORTC-QLQ-C30 questionnaire will be given to participant at inclusion and at 6 months, score will be calculated

  6 months post inclusion

Secondary Outcomes (11)

• compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups

  3 and 6 months after inclusion

• study the effect of 6 months intervention on objective and subjective level of physical activity

  3 months and 6 months after inclusion

• study effect of 6 months of intervention on bone pain (FACT-Bone) evolution

  3 and 6 months post inclusion

• Study effect of 6 months intervention on muscular mass

  6 months post inclusion

• study the effect of 6 months intervention on osteolytic lesion

  6 months post inclusion

Study Arms (2)

Control group

NO INTERVENTION

patient will receive advices about benefit to practice physical activity, only once at the beginning of their treatment. Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later.

Experimental group

EXPERIMENTAL

patient will follow an adapted physical activity program with presential (every 2 weeks the first 3 months, then once a month for 3 months) and distancial (3 times per week for 6 months) sessions.Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later.

Procedure: Adapted physical activity

Interventions

Adapted physical activity PROCEDURE

the intervention is a "real life"6 months adapted physical activity program which is individualised and hybrid (presential and distancial) . It includes a session in presential (at hospital) every 2 weeks for the first 3 months then once a month and 3 sessions par week for 6 months at home.

Experimental group

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed or relapse multiple myeloma, \> 60 yo, not eligible to transplant
• st to 4th line of treatment initiated during the last 3 months
• receiving a systemic treatment that involved visit to the hospital at least twice a month durig the first 3 months and at least once a month the next 3 months

You may not qualify if:

• severe cardiac amyloidosis
• absolute contraindication to physical activity
• inability to comply with the protocol requirements
• not french speaker
• patient under guardianship or curatorship
• pregnant or lactating women

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (2)

CH Annecy Genevois

Annecy, 74374, France

RECRUITING

CH Métropole Savoie

Chambéry, 73000, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Behavior

Central Study Contacts

Charlene DUPRE

CONTACT

+33479965910; charlene.dupre@ch-metropole-savoie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 23, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)